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Washington, DC 20460 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON D.C., 20460 

VIA FACSIMILE: 201-437-4801 

April 19,2012 

Attention: Glenn Merritt (201-437-4000) 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

Subject: Follow-up to fax transmission of 4/13/12 (ePMA removal ofCBI claims regarding 

identified studies) 

Dear Mr. Merritt: 

This is sent to you pursuant our conversation of several minutes ago. In Larry Robinson's fax of 

April 13th while there is a waiver of confidential business information (CBI) claims in the 

identified studies there is a an assertion of copyright protections and some additional text that 

provides in part ... "Reproduction, reference, summarization, retransmission or other use of this 

copyrighted document. .. including electronic transmission, using the internet or email .... is 

strictly prohibited .... " 

While we understand the basis for the copyright protections, we have a concern that the language 

in the fax might be interpreted to mean that ePMA is asserting that the studies submitted per the 

TSCA activity are not to be made available in an Agency e-docket (electronic docket) or be 

included in EPA websites among the collection of TSCA health and safety studies. 

We are thinking that the identified limitations noted in the fax are not intended to apply to EPA's 

normal procedures for the handling of non-CBI materials submitted by entities subject to TSCA 

regulations (including the posting of such materials on government websites) and submitted by 

such entities in order to comply with a TSCA requirement, but are rather intended to limit 

entities outside the government from the unauthorized use or appropriation of the studies. 

Can you please confirm CPMA's intent? Many thanks. 

Scott M. Sherlock, Attorney Advisor 

Environmental Assistance Division 

Office of Pollution Prevention and Toxics 


RE CE E ED

CONFIDENTIAL ~ ~HRC IN-386-1

E~.D. C.

.ACUTE DERMAL TOXICITY

IN THE RABBIT OF

ALKALI BLUE FLUSHINGS

.#FLX-140-443

The Sherwin Williams Comipany Huntingdon Research Center

Chemical Division 216 Congers Road

11541 South Champlain Avenue New City, NY 10956

Chicago, IL 60628
SUMMARY

Alkali Blue #FLX-140-443 was evaluated for its dermal toxicity

in the rabbit according -to the Federal Hazardous Substances Act. The

compound was applied at 2 gm/kg of body weight to the intact and

abraded skin.

Slight erythema was elicited by the compound in four of ten rabbits

during the observation .period. Body weight gain and general appearance

of the rabbits remained good throughout the 14-day observation period.

Based on the results of this study, Alkali Blue #FLX-140-443 would be

considered dermally non-toxic.

Principal Investigator: Y________________

Paul J. Upman

Manager, Non-Rode.nt Toxicology

Approved By: 6~~

Charles 0. Ward, Ph.D.

* Director-, Toxicology

May 4, 1976

jab

-INIKDNRESEARCH CENTER 21,6 CONGERS ROAD NEW CITY, NEW YORK 10956
INTRODUCTI ON

Alkali Blue RFLX-14O-443, was evaluated for Acute Dermal toxicity

in rabbits according to the guidelines of the Federal Hazardous Sub-

*stances Act.

MATERIAL

Alkal'i Blue i#FLX-14O-443 was received as a dark blue paste and

assumed to be 100% active.

METHODS

Ten mature albino rabbits of Ilew Zealand variety were selected from

the stock colony for this study. The compound was applied at 2 gm/kg

body weight to the clipped skin of five intact and five abraded rabbits.

The rabbits were wrapped with a dam. After 24 hours, the wrapping was

removed and thie residue gently washed off. The test site was examined

for erythema and edema and scores were recorded daily for fourteen

days. Body weights were recorded on Days 0, 3, 7, 10 and 14. A gross

examination of the viscera was conducted on all rabbits sacrificed at

fourteen days.

HUJNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956
RESULTS

Daily Observations (Table 1)

Four of ten rabbits exhibited slight erythema through day 3 of the

14-day observation period.- No mortality or unusual behavior or appearance was noted.

Body Weight Gain (Table 11)

Body weight gain was acceptable for all rabbits during the 14-day

study.

Necropsy

Gross examination of the viscera revealed no compound related observations in those rabbits sacrificed after 14 days.

CONCLUSION

Alkali Blue #FLX-140-443 would be considered derrnally non-toxic according to the Federal Hazardous Substances Act.

The dermal LD50 would be estimated at greater than 2 gm/kg body weight.

HUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956
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APPENDIX 1

Evaluation of Skin Reaction Value

Erythema and eschar formation:

No erythema 0

Very slight erythemna -(barely perceptible) 1

Well-defined erythema. 2.

Moderate to severe erythema 3

Severe erythema (beet redness) to slight

.eschar formation (injuries in depth) 4

Edema formation:

No edema0

Very slight edema (barely perceptible) 1

Slight edema (edges of area well defined by

definite raising) 2

Moderate edema (raised approximately

1 millimeter) 3

Severe edema (raised more than 1 millimeter

and extending beyond the area of exposure) 4

-iUNTINGDON RESEARCH CENTER 216 CONGERS ROAD NEW CITY, NEW YORK 10956